Contraception kit

ABSTRACT

The invention relates to a contraception kit that includes at least one regular contraception means for the female cycle as well as an emergency contraception means. The invention is characterized in that both types of contraception means are included in a common packaging.

The present invention relates to a contraceptive kit.

Today the use of regular contraception is widespread in the femalepopulation and provides efficient contraception. However, thiseffectiveness is periodically jeopardized because the contraceptives aresometimes forgotten, thus possibly leading to undesired pregnancies. Theaverage rate of omission for women taking the pill is estimated at 30%per female cycle. The specific measures intended to reduce the risk ofpregnancy in the case of a forgotten pill reach their limits since formost oral contraceptives the contraceptive effectiveness can generallyno longer be ensured when the pill has been taken more than 12 hourslate. However, this safety time limit may be reduced to 3 hours forcertain contraceptive pills. The undesired pregnancy risk is thus evengreater if unprotected sexual intercourse has occurred during the 72hours preceding the omission. The occurrence of an undesired pregnancyleads, in ¾ of cases, to a voluntary termination of pregnancy. Despiteexisting emergency contraception, which reduces the risk of pregnancy ifit is taken within the 3 to 5 days following unprotected intercourse,the number of legal abortions has generally remained stable and has evenincreased for women in the youngest age group. Studies have shown thatthe effectiveness of emergency contraception is time-dependent. It thusappears that in women's everyday life, easy access to emergencycontraception is a major criterion for the improvement of its practicaleffectiveness. Indeed, emergency contraception should ideally be takenas soon as possible after unprotected intercourse or when the pill hasbeen taken with a delay of more than 12 hours. At present, in certaincountries such as France, emergency contraception, depending on itscomposition, may be obtained through medical prescription or sold inpharmacies without prescription, thus reducing the time required to gainaccess to emergency contraception. However, to obtain an emergencycontraceptive, it is necessary to go to a pharmacy. The time between therisky intercourse and access to emergency contraception thus depends onmany factors: the time needed to become aware of the risk and to decideto resort to emergency contraception, the availability of a nearbypharmacy, the opening hours and days of the pharmacy, the availablemeans of transportation. Thus, the availability of non-prescriptionemergency contraception, even though it constitutes an improvement, isnot sufficient. One study (Delotte et al., 2007) has indeed shown thatin 37.7% of cases, minors do not succeed in obtaining emergencycontraception in pharmacies, even though it has been free and anonymousin France since the 2002-39 government decree. Also, even if womenanticipate and purchase an emergency contraceptive before ever needingit, they could loose it between the time when it was purchased and thetime when they need to use it, or they could forget to renew it, so thatby the time they ever need to use it, the emergency contraceptive may beout of date.

According to the above, a problem which the invention aims to solve isthat of increasing the effectiveness of emergency contraceptive meansand, in particular, reducing to the maximum possible extent the timerequired to gain access to an emergency contraceptive means.

The solution proposed by the present invention to solve this problemconsists in providing a contraceptive kit, which comprises, on one hand,a regular contraceptive means for at least one female cycle, and on theother hand, an emergency contraceptive means, characterized in that bothtypes of contraceptive means are present in a common packaging.

The kit according to the present invention allows the above-mentioneddrawbacks to be overcome. In particular, it comprises a regularcontraceptive means and an emergency contraceptive means, wherein bothtypes of contraceptive means are present within a common packaging.Thus, at any given time, the users of a regular contraceptive means mayimmediately have access to an emergency contraceptive means. This allowsthe time required to obtain and take an emergency contraceptive,whenever it is needed, to be effectively reduced to zero. This solutionthus offers women who have forgotten to take their regular contraceptionwithin safe time limits the best possibilities for avoiding undesiredpregnancies. Another advantage is that, with the kit according to thepresent invention, users may access a non-outdated emergencycontraceptive at any given time. Specifically, the kit according to thepresent invention comprises a regular contraceptive means generallydesigned for one to three female cycles, so that the kit may be renewedon a regular basis, advantageously, every month or every 2 or 3 months.The emergency contraceptive means is thus automatically renewed with thesame frequency, before its use-by date has expired. This solution wasunexpected because it was quite unconventional to combine a regularcontraceptive means with an emergency contraceptive means within asingle packaging. Indeed, this solution is contrary to the commonlyaccepted idea that using a regular contraceptive means eliminates theneed for an emergency contraceptive means.

Advantageously, according to the present invention, —the regularcontraceptive means is present in a sufficient quantity to ensurecontraception for at least one female cycle; —the regular contraceptivemeans is oral and comprises contraceptive tablets; —the regularcontraceptive means comprises a contraceptive ring or contraceptivepatch; —the emergency contraceptive means is oral and comprises one ormore emergency contraceptive tablets for emergency contraception takenonly once or twice; —both types of contraceptive means are each packagedin a separate, so-called primary, packaging; the primary packaging forthe regular contraceptive means and the primary packaging for theemergency contraceptive means are joined together by any appropriatemeans, for example gluing or interlocking; —the primary packaging forthe regular contraceptive means and the primary packaging for theemergency contraceptive means are placed in a common packaging referredto as the secondary packaging; —the secondary packaging comprises a box,and each primary packaging comprises a blister pack.

The present invention will be better understood from the followingnon-limiting description.

According to the present invention, the regular contraceptive means or acontraceptive means which is designed for regular contraception mayinclude, but is not limited to, a contraceptive patch, a contraceptivering, or any oral contraception means. An oral contraception means ispreferred, in particular in the form of tablets, generally referred toas pills.

Generally, a regular oral contraceptive means, in particular thecontraceptive pill, is designed to cover one female cycle, or menstrualcycle lasting 28 days, and sometimes 3 to 6 female cycles or more. Theregular oral contraceptive means comprises several contraceptive pills,with one pill to be taken each day during the female cycle. Preferably,one pill should be taken each day for 21, 24, 26 or 28 consecutive days,during each 28-day female cycle. If appropriate, when a contraceptivepill must be taken for 21, 24 or 26 days, it may be complemented by acomplementary pill to be taken during the 7, 4 or 2 remaining days,respectively. This complementary pill may comprise a placebo and/or anestrogen compound alone. Thus, a regular oral contraceptive meansdesigned to cover one female cycle lasting 28 days, preferably comprises21, 24, 26 or 28 contraceptive pills, or up to 6 times as many when itis required to cover up to 6 female cycles. Additionally, a regular oralcontraceptive means may also cover one cycle that has been artificiallyextended to several months. For example, an oral contraceptive may bedesigned for a duration of 84 consecutive days of oral contraceptivetreatment, followed by 7 days of interrupted contraception, with, ifappropriate, the possible taking of one complementary pill, as seenabove. An oral contraceptive may even be designed for a time period of365 days per year, in which an oral contraceptive is taken permanently.

The regular oral contraception is said to be of the single-phase typewhen all the pills to be ingested each day during a female cycle havethe same composition. It is said to be of the multi-phase type with mphases when the pills have m different compositions, with each of thesem compositions specifically corresponding to one time-period of thefemale cycle, where m lies in the range from 2 to 5.

The regular oral contraceptive means, in particular the contraceptivepill, may comprise a so-called estrogen/progestin combination or aprogestin alone or a modulator of the progesterone receptor, that is,hormones which are similar to the estrogens and/or progesterone producedby the ovaries and which block ovulation.

In the case of an estrogen/progestin combination, this may be acombination of an estrogen compound chosen from ethinylestradiol and17-beta-estradiol or estradiol valerate, and a progestin compound,preferably chosen from norgestimate, levonorgestrel, desogestrel,gestodene, drospirenone, nomegestrol acetate, norethisterone,chlormadinone acetate, cyproterone acetate, dienogest and norgestrel.

Each pill may be dosed so as to deliver a daily dose of 40 micrograms ofethinylestradiol or less, or a dose of 2 milligrams of 17-beta estradiolor estradiol valerate or less, as well as a dose of 250 micrograms orless of norgestimate, a dose of 200 micrograms or less oflevonorgestrel, a dose of 150 micrograms or less of desogestrel, a doseof 100 micrograms or less of gestodene, a dose of 3 milligrams or lessof drospirenone, a dose of 5 milligrams or less of nomegestrol acetate,or a dose of 2 milligrams or less of norethisterone, chlormadinoneacetate, cyproterone acetate, dienogest or norgestrel.

In the case where progestin is the only active ingredient, the progestincompound may be chosen from levonorgestrel, desogestrel ornorethisterone. Each pill may be dosed so as to provide a daily dose of30 micrograms or less of levonorgestrel, a dose of 75 micrograms or lessof desogestrel or a dose of 600 micrograms or less of norethisterone.

The regular contraceptive means may also comprise a patch or acontraceptive ring. The contraceptive patch is applied to the skin,generally during the first three weeks of a female cycle, with adifferent patch each week, and the last week of the cycle being spentwithout any patch.

The contraceptive ring is placed deep in the vagina, generally remainsin this position for the first three weeks of a female cycle, and isthen removed during the last week. The patch or the ring delivers thecontraceptive hormones regularly, generally estrogen and a progestin,which block ovulation. Thus, in the case where a patch or a ring is theregular contraceptive means, the kit according to the present inventioncomprises 3 patches or one ring so as to cover the entire female cycle,or may comprise 2 to 6 times these quantities in order to cover 2 to 6female cycles, most often 3 to 6 cycles.

The emergency contraceptive means, or the means designed for emergencycontraception, or the contragestive means, may comprise one or moretablets, conventionally referred to as pills, to be ingested once only.Preferably, the emergency contraceptive means may include 1 tabletcomprising 30 mg of ulipristal acetate, 1 tablet containing 1500micrograms of levonorgestrel or 2 tablets each containing 750 microgramsof levonorgestrel, to be taken once only. The emergency contraceptivemeans may also comprise 4 tablets each containing 50 micrograms ofethinylestradiol and 250 micrograms of levonorgestrel, to be taken in 2doses 12 hours apart.

Alternatively, the emergency contraceptive or contragestive meansconsists of an intrauterine system, in particular an intrauterine devicewhich is inserted by a physician.

According to the present invention, a regular contraceptive means and anemergency contraceptive means are present within a common packaging orpacking. According to a preferred embodiment, both types ofcontraceptive means are each packaged within a separate, so-calledprimary, packaging, and are then brought together by another so-calledsecondary packaging, or packing.

According to another embodiment of the present invention, the primarypackaging of a regular contraceptive and the primary packaging of anemergency contraceptive are combined together, by any appropriate means,for example gluing or interlocking, without necessarily being packedwithin a secondary packaging. Both cases offer the advantage that bothtypes of contraceptive means are accessible together at the same time,in particular, through a single purchase, due to the common packaging,but without being mixed together within said packaging.

Preferably, the primary packaging comprises a blister pack. For example,a blister pack comprises a regular contraceptive means in a sufficientquantity for one female cycle, for example 21, 24, 26 or 28contraceptive pills, and another blister pack comprises an emergencycontraceptive means, for example one or more tablets, in a quantitysufficient for it to be taken only once or twice. The regularcontraception may also be composed, for one cycle, of 3 patches, eachcoated with a protective film, or of a vaginal ring enclosed within aspecific packaging.

Preferably, the secondary packaging may be a box, which contains bothtypes of contraceptive means, each within its primary packaging.Preferably, the packaging combines a regular contraceptive meansintended for one female cycle and an emergency contraceptive means to betaken only once, but it may also comprise a regular contraceptive meansintended for several female cycles and/or one emergency contraceptivemeans to be taken several times. Preferably, a separate primarypackaging is provided for each cycle of regular contraception and aseparate primary packaging is provided for each use of the emergencycontraceptive.

Preferably, the primary packaging has means for distinguishing bothtypes of contraception, for example distinctive colors or symbols.

Alternatively, a regular contraceptive means and an emergencycontraceptive means are associated within a primary packaging andcombined by means of a so-called secondary packaging or packing. Saidprimary packaging or blister pack then comprises two separate areas, onefor the regular contraception and the other one for the emergencycontraception.

The kit according to the invention may further comprise explanatorynotes which promote the proper use of both contraceptive methods. Inparticular, these notes indicate the circumstances and proceduresrelevant to the use of emergency contraception, with respect to thoserelevant to the use of regular contraception, as well as the practicalfollow-up to be observed after such use.

The present invention promotes, in particular, therapeutic education andexchanges between healthcare professionals and women as regards the fullrange of possibilities offered by available birth control means, inorder to reduce the misuse of contraception according to the actualeveryday events in women's lives.

Alternatively, the contraceptive means may also be proposed for theregulation of the menstrual cycle, for the treatment of acne, in thecase of a premenstrual syndrome or for premenstrual dysphoric disorders.In such cases, women might be less observant than when contraception isthe main objective. The usefulness of emergency contraception might thusappear even more clearly in case of need.

The invention is illustrated in the appended drawings.

FIG. 1 shows a top view of a box having 2 primary compartments which arejoined together side by side;

FIG. 2 shows a top view of a box having 2 primary compartments which arejoined together back to back;

FIG. 3 shows a front view of a double-bottom box;

FIG. 4 shows a top view of a 3-compartment box; and

FIG. 5 shows a top view of 2 round or ovoid blister packs interlockedwith each other and each comprising one type of contraceptive.

FIGS. 1 to 5 show different embodiments of a kit according to thepresent invention. In FIG. 1, the secondary packaging is a box 1 having2 compartments 2A and 2B, placed side by side. Compartment 2A, which isthe widest, contains the regular contraceptive, while the othercompartment 2B contains the emergency contraceptive. In compartment 2A,the regular contraceptive intended for each cycle is contained within ablister pack 3, while compartment 2A contains one to six blister packs3, that is, enough for one to six female cycles. In compartment 2B, theemergency contraceptive to be taken only once is contained within ablister pack 4, with compartment 2B preferably containing 1 blister pack4 to be taken only once, and possibly several blister packs 4 to betaken several times. Box 1 may have one opening (not shown), which opensonto both compartments 2A and 2B, or one opening specific to each of thetwo compartments 2A and 2B. In FIG. 2, box 1 also comprises 2compartments 2A and 2B placed back to back, which contain one to sixblister packs 3, respectively, each comprising a regular contraceptivefor one female cycle, and at least one blister pack 4 comprising anemergency contraceptive. Preferably, both compartments 2A and 2B do notopen on the same side, but on the two opposite sides of box 1. In FIG.3, box 1 also comprises 2 compartments 2A and 2B, each with contentssimilar to those shown in the preceding figures. Here, compartment 2B islocated in a double bottom, that is, box comprises an opening for thelargest compartment 2A, whereas an opening for compartment 2B opens atthe bottom of compartment 2A (openings not shown). In FIG. 4A, box 1comprises 3 compartments 2A, 2B and 2C, with the smallest compartment 2Bbeing located between the two others. Compartments 2A and 2C eachcomprise one to three blister packs 3, each comprising one regularcontraceptive for one female cycle, and the center compartment 2Bcomprises at least one blister pack 4 which contains an emergencycontraceptive. Box 1 preferably has three openings, each one for each ofthe three compartments, which open on the same side or on the twoopposite sides of box 1 (openings not shown). Lastly, the embodimentshown in FIG. 5 comprises at least two blister packs, namely a blisterpack and a blister pack 6, with rounded or ovoid shapes. Blister pack 5,which has the largest diameter, has a recess 7 in its center, in whichthe blister pack 6 is placed. The center blister pack 6 contains anemergency contraceptive 8 to be taken at least once, and the outsideblister pack 5 contains a regular contraceptive for one female cycle, inthe form of pills 9 arranged around its circumference. This embodimentmay comprise several blister packs 5 stacked on top of each other, tocover several cycles of regular contraception. Pills 9 of regularcontraceptive may be inserted into a non-return box (not shown), toallow access to one regular pill at a time, for example through awindow, each pill becoming available in turn when the box is rotated.Preferably, as regards the emergency contraceptive 8, it is notaccessible in the same manner. These different embodiments of a kitaccording to the present invention allow an emergency contraceptive tobe available together with a regular contraceptive and in an easilyaccessible manner, but in such a way that it is clearly distinguishablefrom regular contraception.

Of course, the present invention is not limited to the above-describedembodiments, and those skilled in the art will readily adapt theseembodiments through routine operations.

1. A contraceptive kit comprising, on one hand, a regular contraceptivemeans, which covers at least one female cycle, and on the other hand, atleast one emergency contraceptive means, wherein both contraceptivemeans are present in a common packaging and are each packed within aseparate, so-called primary, packaging, and in that the primarypackaging of the regular contraceptive means and the primary packagingof the emergency contraceptive means are joined together by anyappropriate means, for example gluing or interlocking.
 2. Thecontraceptive kit according to claim 1, wherein the regularcontraceptive means is present in sufficient amount to ensurecontraception over at least one female cycle.
 3. The contraceptive kitaccording to claim 1, wherein the regular contraceptive means is oraland comprises contraceptive tablets.
 4. The contraceptive kit accordingto claim 1, wherein the regular contraceptive means comprises acontraceptive ring or contraceptive patch.
 5. The contraceptive kitaccording to claim 1, wherein the emergency contraceptive means is oraland comprises one or more emergency contraceptive tablets for emergencycontraception taken only once or twice.
 6. The contraceptive kitaccording to claim 1, wherein the emergency contraceptive means consistsin an intrauterine system and comprises an intrauterine device. 7-10.(canceled)
 11. The contraceptive kit according to claim 1, wherein theprimary packaging of the regular contraceptive means and the primarypackaging of the emergency contraceptive means are placed in a common,so-called secondary, packaging.
 12. The contraceptive kit according toclaim 11, wherein the secondary packaging comprises a box and in thateach primary packaging comprises a blister pack.
 13. The contraceptivekit according to claim 2, wherein the regular contraceptive means isoral and comprises contraceptive tablets.
 14. The contraceptive kitaccording to claim 2, wherein the regular contraceptive means comprisesa contraceptive ring or contraceptive patch.
 15. The contraceptive kitaccording to claim 2, wherein the emergency contraceptive means is oraland comprises one or more emergency contraceptive tablets for emergencycontraception taken only once or twice.
 16. The contraceptive kitaccording to claim 3, wherein the emergency contraceptive means is oraland comprises one or more emergency contraceptive tablets for emergencycontraception taken only once or twice.
 17. The contraceptive kitaccording to claim 4, wherein the emergency contraceptive means is oraland comprises one or more emergency contraceptive tablets for emergencycontraception taken only once or twice.
 18. The contraceptive kitaccording to claim 2, wherein the emergency contraceptive means consistsin an intrauterine system and comprises an intrauterine device.
 19. Thecontraceptive kit according to claim 3, wherein the emergencycontraceptive means consists in an intrauterine system and comprises anintrauterine device.
 20. The contraceptive kit according to claim 4,wherein the emergency contraceptive means consists in an intrauterinesystem and comprises an intrauterine device.
 21. The contraceptive kitaccording to claim 12, wherein the emergency contraceptive meansconsists in an intrauterine system and comprises an intrauterine device.22. The contraceptive kit according to claim 13, wherein the emergencycontraceptive means consists in an intrauterine system and comprises anintrauterine device.
 23. The contraceptive kit according to claim 14,wherein the emergency contraceptive means consists in an intrauterinesystem and comprises an intrauterine device.
 24. The contraceptive kitaccording to claim 15, wherein the emergency contraceptive meansconsists in an intrauterine system and comprises an intrauterine device.